Skip to main content
OpenTrials
Completed

NCT Number: NCT02256059

Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension

Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

About this study

Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.

In this prospective study patients with dislocated fractures of the lateral clavicle (Jäger&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability is evaluated using the Taft-Score.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dislocated fracture of the lateral clavicle
  • Informed consent.

Exclusion criteria

  • Patients with a history of any other pathology such as preexisting rotator cuff tear, gleno-humeral instability, glenohumeral osteoarthritis (> Samilson I), Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying tendonitis, biceps pathology or signs of cervical root symptoms

Treatment and study plan

Plate osteosynthesis

Procedure

Plate osteosynthesis using LCP plate (Synthes)

Primary outcomes

  1. bone healing

    Time frame: 12 month

    time until bone healing, visualized using conventional x-ray in two planes

Secondary outcomes

  1. shoulder function

    Time frame: 12 month

    shoulder function assessed using Munich Shoulder Questionnaire [MSQ]

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study

Acronym: LatClav

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 3, 2014
Registry last updated
Oct 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.